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510(k) K934751

ACTIVE ANDROSTANEDIOL GLUCURONIDE by Diagnostic Systems Laboratories, Inc. — Product Code CIZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1994
Date Received
October 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Androstenedione
Device Class
Class I
Regulation Number
862.1075
Review Panel
CH
Submission Type

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Other clearances for product code CIZ

  • K963002 — ACTIVE ANDROSTENEDIONE EIA (August 16, 1996)
  • K954755 — COAT-A-COUNT DIRECT ANDROSTENEDIONE (November 29, 1995)
  • K860559 — ANDROSTENEDIONE 125I KIT BY RIA (March 14, 1986)
  • K854673 — DSL ANDROSTENEDIONE RIA (DSL # 4200) (January 22, 1986)
  • K854650 — DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) (December 13, 1985)
  • K844398 — COAT-A-COUNT ANDROSTENEDIONE RIA KIT (December 10, 1984)
  • K842960 — ANDROSTENEDIONE BY RIA (September 27, 1984)
  • K832452 — ANDROSTENEDIONE TEST SET 125I (September 12, 1983)
  • K801729 — ANDROSTENEDIONE RADIOIMMUNOASSAY KIT (October 31, 1980)